NCT00811850

Brief Summary

A 10 week evaluation, crossover design study including a 3 week washout period between treatments, to determine the effects of Combigan® (fixed combination brimonidine tartrate 0.2%/timolol maleate 0.5%) and Cosopt® (fixed combination dorzolamide hydrochloride-timolol maleate ophthalmic solutions) on ocular blood flow as measured by retrobulbar blood flow.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 1, 2012

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

December 17, 2008

Results QC Date

October 24, 2011

Last Update Submit

April 10, 2019

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (8)

  • Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery

    Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).

    1 Month

  • Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery

    End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).

    1 Month

  • Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery

    Peak systolic velocity (PSV) of retrobulbar blood as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in the blood vessel).

    1 Month

  • Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery

    End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).

    1 Month

  • Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery

    Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).

    1 Month

  • Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery

    End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).

    1 Month

  • Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery

    Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).

    1 Month

  • Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery

    End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).

    1 Month

Study Arms (2)

Combigan®

ACTIVE COMPARATOR

Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.

Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution

Cosopt®

ACTIVE COMPARATOR

Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.

Drug: fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution

Interventions

fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solutionDRUG

1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks

Also known as: Combigan®
Combigan®
fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solutionDRUG

1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks

Also known as: Cosopt®
Cosopt®

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 30 years or older.
  • Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye.
  • Best corrected visual acuity at least 20/40 in at least one eye.

You may not qualify if:

  • History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
  • History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
  • History or signs of intraocular trauma.
  • Any abnormality preventing reliable applanation tonometry.
  • Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
  • Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Indianapolis, Indiana, United States

Location

Related Publications (1)

  • Siesky B, Harris A, Ehrlich R, Cantor L, Shoja MM, Rusia D, Hollander DA, Abrams L, Williams JM, Shoshani Y. Short-term effects of brimonidine/timolol and dorzolamide/timolol on ocular perfusion pressure and blood flow in glaucoma. Adv Ther. 2012 Jan;29(1):53-63. doi: 10.1007/s12325-011-0092-3. Epub 2012 Jan 11.

    PMID: 22246943BACKGROUND

MeSH Terms

Conditions

Glaucoma

Interventions

TimololOphthalmic SolutionsBrimonidine Tartrate, Timolol Maleate Drug Combinationdorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsBrimonidine TartrateQuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDrug Combinations

Results Point of Contact

Title
Vice President, Medical Affairs
Organization
Allergan, Inc.
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 19, 2008

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 24, 2019

Results First Posted

August 1, 2012

Record last verified: 2019-04

Locations

US(1)